Indonesia clears dsm-firmenich’s 2’-FL HMO ingredient for commercial use

Indonesia Biosafety Clearing House has granted dsm-firmenich safety clearance for its Escherichia coli K-12 DH1 MDO strain for 2’-Fucosyllactose (2’-FL) production. This approval secures market access for the company’s 2’-FL human milk oligosaccharide (HMO) ingredient — commercially known as Glycare 2FL 9000 — in flavored liquid milk drinks for ages three and older.

The commission also found that dsm-firmenich’s 2’-FL ingredient does not show any potential to cause allergies, is classified as a non-toxic substance, and is safe for consumption as a food ingredient.

“This safety clearance is a significant step forward in dsm-firmenich’s mission to improve access to HMOs worldwide, with ingredients from our Glycare HMO portfolio now available for use in more than 165 countries,” comments Elaine Tan, regulatory affairs manager for the Asia-Pacific team at dsm-firmenich.

“Emerging evidence shows a myriad of health benefits provided by HMOs in early life nutrition, through childhood and beyond,” adds Anita Wichmann, lead expert in Regulatory Affairs for Early Life Nutrition, Medical Nutrition, and HMOs at dsm-firmenich.

“The newly secured market access for Glycare 2FL 9000 opens new opportunities for innovators in Indonesia to harness these benefits in nutritional solutions that support the gut health of children and adults.”

Spotlight on HMOs

HMOs, including 2’FL, are a key component of human breast milk, which is widely considered the gold standard for infant nutrition.

A growing body of evidence demonstrates that these ingredients can support the gut microbiota, digestive health, and immunity of infants, children, and adults.

Last month, functional ingredients manufacturer Beneo and Wacker, a European chemical supplier of biotechnology solutions, launched their 2’-FL ingredient globally.

Beneo expects the global demand for HMOs to grow significantly, from around US$180 million in 2022 to almost US$900 million by 2032, reflecting a compound annual growth rate of more than 17%.

This predicted growth is supported by an increasing number of infant-formula product launches featuring HMOs, which rose from 4% to 20% between 2018 and 2023.